EN 14820:2004

Single-use containers for human venous blood specimen collection

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.
This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.

Gefäße zur einmaligen Verwendung für die venöse Blutentnahme beim Menschen

Dieses Dokument legt Anforderungen an und Prüfungen für Gefäße zur einmaligen Verwendung fest, die von ihrem Hersteller zur Entnahme von Venenblut aus dem menschlichen Körper für eine in-vitro-diagnostische Untersuchung bestimmt sind. Dieses Dokument gilt auch für Gefäße, die Nährmedien für Blutkulturen enthalten.
Dieses Dokument legt keine Anforderungen an Gefäße zur Blutentnahme aus Kapillaren oder Arterien fest. Sie legt auch keine Anforderungen an und Prüfverfahren für Gefäße zur einmaligen Verwendung fest, die zur Aufnahme anderer Proben als Blut bestimmt sind.

Récipients à usage unique pour prélèvements de sang veineux humain

La présente norme spécifie les exigences et méthodes d'essai relatives aux récipients à usage unique destinés par le fabricant aux prélèvements de sang veineux humain dans le but d'examens diagnostiques in vitro. La présente norme s'applique également aux récipients contenant des milieux pour hémoculture.
La présente norme ne spécifie pas d'exigences relatives aux récipients d'échantillons sanguins capillaires, ni aux récipients d'échantillons sanguins artériels. La présente norme ne spécifie pas d'exigences ni de méthodes d'essai relatives aux récipients à usage unique prévus pour le prélèvement d'échantillons autres que le sang.

Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2004
• Withdrawal Date: 05-Sep-2017
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Sep-2017
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 14820:2005 - Single-use containers for human venous blood specimen collection

Relations

• Replaced By: EN ISO 6710:2017 - Single-use containers for human venous blood specimen collection (ISO 6710:2017)
• Effective Date: 13-Sep-2017

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Single-use containers for human venous blood specimen collectionKontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabiRécipients a usage unique pour prélevements de sang veineux humainGefäße zur einmaligen Verwendung für die venöse Blutentnahme beim MenschenTa slovenski standard je istoveten z:EN 14820:2004SIST EN 14820:2005en11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:SLOVENSKI
STANDARDSIST EN 14820:200501-marec-2005

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14820September 2004ICS 11.040.20 English versionSingle-use containers for human venous blood specimencollectionRécipients à usage unique pour prélèvements de sangveineux humainGefäße zur einmaligen Verwendung für die venöseBlutentnahme beim MenschenThis European Standard was approved by CEN on 27 May 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14820:2004: E

Test for nominal liquid capacity and graduation marks, for non-evacuated blood specimen receptacles.12 A.1 Reagents and apparatus.12 A.2 Test conditions.12 A.3 Test procedure.12 Annex B (normative)
Tests for draw volume for evacuated receptacles.13 B.1 Reagents and apparatus.13 B.2 Test conditions.13 B.3 Test procedure.13 Annex C (normative)
Test for leakage from the closure of a receptacle.14 C.1 Reagents and apparatus.14 C.2 Test procedure for non-evacuated container.14 C.3 Test procedure for evacuated receptacles.14 Annex D (normative)
Test for the robustness of a receptacle that is intended for centrifugations.16 D.1 Reagents and apparatus.16 D.2 Test conditions.16 D.3 Test procedure.16 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 98/79/EC.17 Bibliography.19

3.11 graduation mark mark on a container, or its label, to enable an estimation to be made of the volume of the specimen 3.12 gravimetric analysis method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid NOTE For the purposes of this document 1,000 ml of water is considered to have a mass equal to 1,000 g. 3.13 maximum fill line mark on a container or its label, to indicate the maximum volume of specimen permitted to ensure that the in vitro diagnostic test for which the specimen is intended, will give accurate results 3.14 minimum fill line mark on a container, or its label, to indicate the minimum volume of specimen required to ensure that the in vitro diagnostic test, for which the specimen is intended, will give accurate results 3.15 needle and holder assembly device that is intended to be attached to an evacuated receptacle to enable venous puncture and subsequent blood collection to be performed 3.16 nominal liquid capacity volume of specimen with which the receptacle is intended to be filled plus the volume of any additive NOTE This volume is stated on the label and/or instructions for use. 3.17 nominal fill line mark on a container, or its label, to indicate the nominal liquid capacity of a receptacle 3.18 primary pack smallest pack of receptacles

4 Materials 4.1 If a receptacle is intended to contain a specimen for a specific examination, where the material of the closure, or container, or the interior coating, or the additive, or accessory, if present, may affect the final results of the examination, then the maximum level of the contamination with that substance, and the analytical method employed, shall be stated by the manufacturer in accompanying literature, or on the label, or packaging (see also 11.3). Validation of the suitability of material with regard to a receptacle's specifically intended use is the responsibility of the manufacturer. NOTE 1 This document does not specif
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